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Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15)

Phase 2
Open (Enrolling)
Relapsed Lymphoma, B Cell Non-Hodgkin Lymphoma, Refractory Lymphoma, High Risk Chronic Lymphocytic Leukemia

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Trial Information

Lymphodepleting Chemotherapy With Rituximab and Allogeneic Natural Killer Cells for Patients With Refractory Lymphoid Malignancies (MT2009-15)

Inclusion Criteria:

- Patients of any age with diagnosis of:

- Relapsed/refractory lymphoma (B cell non-Hodgkin) who have lack of objective
response to at least two prior chemotherapy regimens

- Relapsed chronic lymphocytic leukemia with high risk features: lack of objective
response or relapse within 6 months following nucleoside-analogue based
chemotherapy regimen or patients with 17p deletion CLL who lacked objective
response to at least 1 preceding chemotherapy regimen

- Available related HLA haploidentical NK cell donor by at least Class I serologic
typing at the A&B locus (age 12-75 years)

- Karnofsky > 70% for patients 16 years and older and Lansky play score > 50 for
patients under 16 years of age

- Measurable disease based on modified Response Evaluation Criteria in Solid Tumors

- Have acceptable organ function as defined within 28 days of enrollment:

- Hematologic: platelets ≥ 80,000 x 10^9/L; hemoglobin ≥ 9 g/dL, unsupported by
transfusions within 7 days; absolute neutrophile count (ANC) ≥ 1000 x 10^9/L,
unsupported by Granulocyte colony-stimulating factor (G-CSF) or
Granulocyte-Macrophage Colony Stimulating Factor (GM-CSF) for 10 days or
Neulasta for 21 days - the hematologic requirements are waived for patients with
inadequate counts due to known bone marrow involvement by disease who are
otherwise eligible

- Renal: calculated glomerular filtration rate (GFR) > 50 ml/min

- Hepatic: Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) < 5
x upper limit of normal and total bilirubin ≤3 mg/dl - hepatic requirements are
waived for patients with known disease involvement in the liver if otherwise

- Pulmonary function: >40% corrected Carbon Monoxide Diffusing Capacity (DLCO) and
Forced expiratory volume in one second (FEV1) (oxygen saturation [>92%] can be
used in child where pulmonary function tests (PFT's) cannot be obtained)

- Cardiac: no symptoms of uncontrolled cardiac disease, left ventricular ejection
fraction ≥ 40%

- Able to be off prednisone or other immunosuppressive medications for at least 3 day
prior to Day 0 (excluding denileukin diftitox pre-medications)

- Sexually active women of childbearing potential must agree to use adequate
contraception (diaphragm, birth control pills, injections, intrauterine device [IUD],
surgical sterilization, subcutaneous implants, or abstinence, etc.) for the duration
of treatment.

- Voluntary written consent

Exclusion Criteria:

- Pregnant or lactating. The agents used in this study may be teratogenic to a fetus
and there is no information on the excretion of agents into breast milk. All females
of childbearing potential must have a blood test or urine study within 14 days prior
to enrollment to rule out pregnancy. Women of childbearing age must use appropriate
contraceptive method.

- Active central nervous system (CNS) lymphoma/leukemia - Patients with prior CNS
involvement are eligible provided that it has been treated and is in remission.

- Active serious infection (pulmonary infiltrates or lesions are allowed only after the
appropriate diagnostic testing is negative for infection or appropriate therapy was
initiated for probable infection)

- Pleural effusion large enough to be detectable on chest x-ray (CXR)

- Evidence of human immunodeficiency virus (HIV) infection or known HIV positive

- Active concurrent malignancy (except skin cancer)

- Epstein-Barr virus (EBV) post-transplant lymphoproliferative disorder

- Positive HBsAg. If HBcAb is positive, Hepatitis B DNA by PCR will be evaluated.
Positive anti HBcAb with an undetectable viral load does not exclude the patient.

- Any investigational therapy in the past 30 days

- Patients following allogeneic stem cell transplantation are eligible in the absence
of graft versus host disease and are off immunosuppression for at least 30 days

- Known allergy to any of the study agents

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Objective Response Rate

Outcome Description:

The proportion of patients with an objective response rate (Partial Response +Complete Response) at 2 months post haploidentical NK cell infusion in patient with refractory/relapsed NHL or chronic lymphocytic leukemia (CLL).

Outcome Time Frame:

Month 2 Post Infusion

Safety Issue:


Principal Investigator

Veronika Bachanova, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Masonic Cancer Center, University of Minnesota


United States: Food and Drug Administration

Study ID:




Start Date:

August 2010

Completion Date:

August 2014

Related Keywords:

  • Relapsed Lymphoma
  • B Cell Non-Hodgkin Lymphoma
  • Refractory Lymphoma
  • High Risk Chronic Lymphocytic Leukemia
  • related HLA-haploidentical donor
  • Leukemia
  • Leukemia, Lymphocytic, Chronic, B-Cell
  • Leukemia, Lymphoid
  • Lymphoma
  • Lymphoma, Non-Hodgkin
  • Lymphoma, B-Cell



Masonic Cancer Center, University of Minnesota Minneapolis, Minnesota  55455